CT-P13 (biosimilar infliximab) is comparable to reference infliximab and adalimumab in highly anticipated real-world study.
Twelve-month data from the Personalized Anti-TNF therapy in Crohn’s disease Study (PANTS) was presented at the 13th Congress of the European Crohn’s and Colitis Organization (ECCO).
The results indicate that the clinical effectiveness, safety and immunogenicity of Celltrion Healthcare’s CT-P13 (biosimilar infliximab) in patients with Crohn’s disease (CD) is comparable to those treated with reference infliximab as well as those treated with adalimumab.1
The U.K.-wide, three-year prospective observational study investigated primary non-response (PNR), loss of response (LOR) and adverse drug reactions (ADR) to infliximab (reference infliximab and CT-P13) and adalimumab in 1610 CD patients.
The data show comparable efficacy between CT-P13, reference infliximab and adalimumab in relation to PNR, LOR, and ADR rates. In addition, at week 54, the remission rate was 39.7 percent, 39.0 percent, and 32.7 percent, for reference infliximab, CT-P13 and adalimumab treated patients, respectively.1
The PANTS study investigates patient, drug, and pharmacokinetic factors that predict anti-TNF treatment failure with the aim of developing personalized anti-TNF strategies to improve patient outcomes. This large real-world prospective cohort study provides valuable data on clinical effectiveness as well as biologic samples for genomic studies.1
“We strongly believe that this type of research is essential to developing cost effective, treatment strategies for patients with inflammatory bowel disease in order to maximize benefit,” PANTS study investigator Dr. Tariq Ahmad, head of the Inflammatory Bowel Disease and Pharmacogenetics Research Group at the University of Exeter, and consultant gastroenterologist at the Royal Devon and Exeter Hospital U.K., said. “The results from PANTS suggest there are opportunities to optimize the management of anti-TNF therapies and to prevent treatment failure.”
According to the study, immunogenicity is a significant factor in non-remission for both infliximab and adalimumab treated patients at week 54 but can be mitigated by the use of immunomodulators—azathioprine, mercaptopurine, and methotrexate. The PANTS study has demonstrated that this risk is in part genetically determined and as such personalized treatment algorithms may be developed in the future.1
“The PANTS results clearly show that the careful optimization of CT-P13, reference infliximab and adalimumab as part of routine care may make these treatments more effective for patients with inflammatory bowel disease,” Man Hoon Kim, president and CEO of Celltrion Healthcare, said. “Therefore, given the significant cost savings in using CT-P13, this treatment has the potential to play a huge role in increasing patient access to biological treatment and improving outcomes.”
IBD Patient Group Supports Targeted and Personalized Treatment
In a Celltrion Healthcare satellite symposium held at the congress, The European Federation of Crohn’s and Ulcerative Colitis Association’s (EFCCA) vice-president Salvo Leone led a presentation on the “Accumulated Experience with Biosimilars,” which highlighted the need for more personalized medicines in order to improve the quality of life and well-being of people with IBD.
1 Kennedy, N.A. et al. Clinical effectiveness, safety and immunogenicity of anti-TNF therapy in Crohn’s Disease: 12 month data from the PANTS study Congress of the European Crohn’s and Colitis Organization (ECCO) 2018. OP031
(Source: Celltrion Healthcare via Business Wire)
Filed Under: Drug Discovery